Making Sense of Corrective/Preventive Actions in ISO 9001
Making Sense of Corrective/Preventive Actions in ISO 9001
A Common Sense Guide for Hospitals Using NIAHO/ISO 9001
Making Improvement Work
December 17, 2013
Continuous Improvement via the CAPA System
This is the second in a series of quick lessons in the 6 required documented procedures of ISO
9001 – 1) Document Control, 2) Record Control, 3) Internal Audit, 4) Control of Nonconforming Product, 5) Corrective Action, and 6) Preventive Action. These lessons are for
hospitals’ adopting ISO 9001 – and this one is focused on making corrective and preventive
action procedures required by ISO really deliver results.. These are designed to be 10 minute
reads – introducing some concepts that I’ve found valuable.
Product defects in medicine are an awful concept – make your CAPA system work!
ISO is pretty straight forward about fixing problems – including both corrective and
preventive actions –“…The organization shall take action to eliminate the causes of
[potential] nonconformities [defects, failures and problems] in order to prevent their
[occurrence] recurrence. Corrective actions [preventive actions] shall be appropriate to
the effects of the [potential problems] nonconformities encountered. (Section 8.5.2 & .3
Paraphrasing from the standard, this requires: 1) Review of actual and potential problems,
2) determining the root cause of the problem(s), 3) Evaluating the need for action, 4)
Determining and implementing the action required, 5) Recording the results of the
actions taken, and 6) Reviewing the effectiveness of the actions. In layman’s terms –
identify the problem, determine the root cause, plan the fix, fix it, and prove that it was
actually fixed with real world data.
If this sounds like an invitation to apply your favorite Lean/Six Sigma (LSS) tools – you
are absolutely correct. The maddening thing about ISO, is that it sets up the framework to
use all of your favorite quality tools, but never once mentions them be name – or even
suggests their use. For many old hands at process improvement – but new to ISO – this
omission seems a heresy. How could ISO never once even imply the use of the process
improvement tools that have revolutionized the concepts of process improvement (PI)
The answer – ISO is not prescriptive. But it does offer the best quality management
system (QMS) ever invented to make LSS tools effective in complex systems like
modern hospitals (check out my white paper onComplex Medical Quality Systems).
Three Practical Considerations - Making a CAPA System Work
First, One System Only!
This is the single most important consideration for senior management – only have one
process improvement system – and for ISO 9001compliant facilities this must be the
CAPA system. This is the hardest thing to achieve – and the most important. No clinical
care delivery system can support multiple uncoordinated performance improvement
efforts. Invariably, they end up contradicting each other and the process changes almost
never filter back into the documented P&P system, which is legally required to control all
Most facilities that I visit have a minimum of four disparate PI systems functioning in
“parallel universes”: 1) Some form of committee based P&P system – controlled through
accreditation standards (TJC or DNV), 2) Some form of PI process improvement effort
focused on Lean & Six sigma tools (including TPS, PDSA, A3 etc.), 3) Some top-down
clinical improvement effort (often involving 3rd party consultants) focused on Infection
Control, Serious Reportable Events (SREs)etc., and 4) A variety of department level
initiatives, idiosyncratic in goals, staffing and methods.
A good CAPA system easily accommodates all of these PI efforts, and rolls them into a
single conformable system. The CAPA system allows senior management to:
Understand and control all improvement efforts in a single system,
Conform all PI efforts to a single execution methodology,
Utilize any PI tools or third party consultants,
Understand the problem being addressed, define the steps to fix/prevent it,
prove that the solution has been effective, and monitor ongoing effectiveness.
Second - Tier the CAPA system to reflect Risk and Impact (Cost & Care)
Not all problems are created equal – that’s why we evaluate risk and potential cost and
care impact. The appropriate response to a Sentinel Event is very different than the need
for a small 5S project in an outpatient clinic.
I normally recommend a 3 tier CAPA system:
1. SRE CAPAs – these are any corrective/preventive action that you don’t want
your Chairman reading about in the newspaper – without hearing from you first.
These should be less than 1% of the total CAPAs, but will take about a third of
the time for resolution. SRE CAPAs are normally related to complex problems,
and require a cascade of failure to come to full fruition.
2. Normal CAPAs – done to address actual or potential problems and nonconformities, and resolved via the normal, complete CAPA process. Normal
CAPAs should be 20-30% of the total CAPA load, but account for 40-50% of
total project time, and
3. Penalty Box tickets – a “CAPA light” which is really a counting or operational
audit function to determine the scale of recurring problems and/or the
completion of selective repetitive procedures. These are called penalty box
tickets, because like in hockey, they are designed to be resolved in 2 minutes or
less. PB Tickets should be the vast majority of total projects, but should not take
more than one third of total work time in resolution.
SRE CAPAs ≤ 1%
% of total
Type of Failure
events. High risk,
cost and exposure.
failure or simple
This needs to be the area
of senior management
preventive action. Bow-tie
Most LSS projects fit into
this category. Most
departmental projects fit
Simple and very valuable
Third – You have the tools – use them!
Get some help from your PMI trained folks. I always run my own CAPA systems like a
single project management system. I like a simple user interface for active projects, with
a simple dashboard for projects underway and key operational metrics on the same
platform. Running operational metrics with projects allows the easy detection of post
project impact on expected outcomes. If the outcomes don’t materialize – the sooner it is
exposed the better. Keeping metrics running in the background for completed projects is
a very good idea – provided that the data is sourced automatically. Fixing things is easy –
keeping them fixed is a whole different problem.
Simple Project Mgt. Tools Drive the CAPA System
Most hospitals staffs are hardened to the “new-new-thing” phenomena in process
improvement and quality. My experience is that most busy clinical staffpersonnel are
looking to reduce the aggregate burden of quality compliance – and walking in the door
with yet another new quality system/tool is not welcome. When I put in a new CAPA
system, I’ve had the best luck calling it (and operating it) as a project management
system. The CAPA system is simply the way projects will be initiated, run and evaluated.
Let your LSS system live inside the CAPA system – and make sure that people use it! I
have seen way too many situations where, “XYZ department won’t use LSS tools.” There
are a number of terrific LSS cloud based integrated project packages available today.
These offer a number of major advantages:
They force compliance with a standardized PM system
They provide a consistent framework for CAPA analysis and resolution
They provide access across multisite organizations
They allow real time project update and analysis
They are Fair and Transparent.
The CAPA system is the heart of value delivery in ISO. If your CAPA system doesn’t
work, things don’t get better – so what is the point. I’ve run good CAPA systems, and
suffered through bad ones. Let me know if I can help.